1. Field of Inventions
The present inventions relate generally to expandable diagnostic or therapeutic apparatus and the devices that are used to introduce expandable diagnostic or therapeutic apparatus into the body.
2. Description of the Related Art
There are many instances where physicians must introduce expandable diagnostic or therapeutic apparatus, such as three-dimensional mapping baskets and inflatable soft tissue coagulation structures, into the body. The diagnostic or therapeutic apparatus are often carried by catheters that allow physicians to gain access to the body in a minimally invasive manner by way of bodily lumens. In cardiac treatment, for example, a catheter is advanced through a main vein or artery into the region of the heart that is to be treated.
One method of introducing diagnostic or therapeutic apparatus into the body is to introduce a tubular member (typically a xe2x80x9csheathxe2x80x9d) into the vicinity of the target body region. The diagnostic or therapeutic apparatus is often positioned near the distal end of the sheath in a collapsed state as the sheath moves to the target region. Once there, the physician holds the sheath in place with one hand and advances the diagnostic or therapeutic apparatus with the other hand distally beyond the sheath where it expands into contact with tissue in the target region. Alternatively, the sheath may be advanced to the target region prior to the insertion of the diagnostic or therapeutic apparatus. Once the sheath is in place, the diagnostic or therapeutic apparatus is inserted through the sheath to the target region.
Precise placement of the diagnostic or therapeutic apparatus is very important and the distal regions of some conventional sheaths have a preset curvature which corresponds to a particular target region in order to facilitate the precise placement. With respect to cardiac mapping procedures, for example, as many as four different sheaths are used to facilitate precise placement in the four pulmonary veins. A variety of sheathes and basket catheters are separately sold and stored. The physician must select the sheaths for a particular procedure prior to the procedure itself.
The inventor herein has determined that the presently available apparatus for deploying expandable diagnostic or therapeutic apparatus is susceptible to improvement.
For example, the inventor herein has determined that the process of holding the sheath in place with one hand and while advancing the diagnostic or therapeutic apparatus with the other burdensome because it requires the use of both hands. One proposed solution would be to simply permanently couple the sheath and the diagnostic or therapeutic apparatus to a handle that moved the diagnostic or therapeutic apparatus relative to the sheath. Such an arrangement is illustrated in U.S. Pat. No. 5,309,910. The inventor herein has determined that, while useful, this permanently coupled arrangement precludes the use of multiple sheaths of differing preset curvature with the same diagnostic or therapeutic apparatus.
The inventor herein has also determined that another issue associated with presently available apparatus for deploying expandable diagnostic or therapeutic apparatus is convenience, i.e. it can be inconvenient to select, retrieve from storage, and prepare a variety of separately sold and stored devices prior to each procedure.
Accordingly, the general object of the present inventions is to provide a device that avoids, for practical purposes, the aforementioned problems. In particular, one object of the present inventions is to provide a device that makes it relatively easy for the physician to move a diagnostic or therapeutic apparatus relative to a sheath, without precluding the use of multiple sheaths with the same diagnostic or therapeutic apparatus. Another object of the present inventions is to provide an electrophysiological procedure kit that will eliminate the aforementioned inconvenience associated with separately sold and stored devices.
In order to accomplish some of these and other objectives, an assembly in accordance with one embodiment of a present invention includes an apparatus having an elongate body and an expandable/collapsible device carried by the distal portion of the elongate body, a tubular member defining a lumen configured to receive the apparatus, and a handle, fixedly connected to the elongate body and removably connected to the tubular member, configured to move at least one of the elongate body and the tubular member relative to the other.
The present assembly provides a number of advantages over conventional apparatus for deploying expandable diagnostic or therapeutic apparatus. For example, the present handle allows the physician to move the expandable/collapsible device relative to the tubular member with one hand.
Moreover, because the tubular member is removably secured, a variety of tubular members can be used with the same handle and expandable/collapsible device.
In order to accomplish some of these and other objectives, an electrophysiological procedure kit in accordance with one embodiment of a present invention includes a plurality of tubular members defining a different predetermined characteristic (such as distal portion curvature) and an electrophysiological apparatus including an elongate body, an expandable/collapsible device carried by the elongate body, a handle fixedly connected to the proximal portion of the elongate body and configured to be individually removably connected to the proximal portions of the tubular members. The handle is configured to move the elongate body and a removably connected tubular member relative to one another.
The kit may be provided with all of the tubular members required for a particular set of procedures involving the electrophysiological apparatus such as, for example, mapping the chambers of the heart. One advantage of such a kit is convenience in that opening a ready to use kit is far more convenient than collecting a number of separately sold and stored devices and preparing them for the procedure. Moreover, the electrophysiological apparatus may be positioned within the first tubular member that will be used in the procedure during assembly of the kit to further increase the convenience for the physician.
The above described and many other features and attendant advantages of the present inventions will become apparent as the inventions become better understood by reference to the following detailed description when considered in conjunction with the accompanying drawings.